[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658276":3},{"organization":4,"outcomesModule":7,"designInfo":79,"detailedDescription":91,"studyPopulation":84,"armGroups":92,"interventions":105,"overallOfficials":114,"centralContacts":119,"locations":129,"responsibleParty":146,"collaborators":84,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":84,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":176,"whyStopped":84,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"University of Oxford","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Auditory Verbal Learning Test (AVLT)","Verbal learning and memory will be assessed using the Auditory Verbal Learning Test, including measures of immediate recall, delayed recall, and recognition memory. AVLT performance will be compared between prucalopride and placebo groups following the intervention.","Day 14 (post-intervention)",[14,18,22,25,28,31,34,38,42,46,50,54],{"measure":15,"description":16,"timeFrame":17},"Sleep outcomes measured using wearable sleep monitoring","Sleep will be assessed using a wearable chest patch in a subset of participants (n=20 total, 10 per intervention group). Measures will include sleep duration, sleep quality and sleep staging. Sleep outcomes will be compared between the prucalopride and placebo groups.","Baseline (Day 0) and Days 1-4 of the intervention",{"measure":19,"description":20,"timeFrame":21},"Digit Span Task","Maximum digit span will be assessed as a measure of working memory and compared between the prucalopride and placebo groups","Baseline and Day 14 (post-intervention)",{"measure":23,"description":24,"timeFrame":12},"Emotional Go\u002FNo-Go (EGNG)","Inhibitory control will be assessed using the EGNG task, including measures of commission errors, omission errors, and reaction time. Performance will be compared between prucalopride and placebo groups follwing the intervention.",{"measure":26,"description":27,"timeFrame":12},"Probabilistic Reversal Learning Task (PRL)","Cognitive flexibility and reward-based learning will be assessed using the PRL task, including measures such as response accuracy, reversal errors, and sensitivity to reward and punishment. Performance will be compared between prucalopride and placebo groups following the intervention.",{"measure":29,"description":30,"timeFrame":12},"Mnemonic Similarity Task (MST)","Pattern separation and recognition memory will be assessed using the MST. Performance will be compared between the prucalopride and placebo groups following the intervention.",{"measure":32,"description":33,"timeFrame":12},"Serial Addition Task (SAT)","Working memory will be assessed using the SAT. Performance will be compared between the prucalopride and placebo groups following the intervention",{"measure":35,"description":36,"timeFrame":37},"Matrix Span Task","Visual working memory assessed using the Matrix Span Task, administered remotely via the NeuroUX app. Performance (accuracy\u002Freaction time) will be compared between prucalopride and placebo groups.","Baseline and Days 2, 3, 5, 6, 8, 10, 11 and 13 of the 14-day intervention.",{"measure":39,"description":40,"timeFrame":41},"Variable Difficulty List Memory Test (VDLMT)","Verbal learning and recognition memory will be assessed using the VDLMT, administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.","Baseline and Days 1, 2, 4, 6, 7, 9, 11, 12 and 14 of the 14-day intervention.",{"measure":43,"description":44,"timeFrame":45},"N-Back Test","Working memory will be assessed using the 2-back version of the N-back task, administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.","Baseline and Days 1, 3, 4, 6, 8, 9, 11, 13 and 14 of the 14-day intervention.",{"measure":47,"description":48,"timeFrame":49},"Digit Symbol Substitution Task (DSST)","Processing speed will be assessed using the DSST, administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.","Baseline and Days 1, 3, 5, 7, 8, 10, 12 and 13 of the 14-day intervention.",{"measure":51,"description":52,"timeFrame":53},"Quick Tap 2 Test","Response inhibition will be assessed using the Quick Tap 2 test, a go\u002Fno-go task administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.","Baseline and Days 2, 4, 5, 7, 9, 10, 12 and 14 of the 14-day intervention.",{"measure":55,"description":56,"timeFrame":12},"Paired Associates Learning (PAL)","Verbal associative and episodic memory will be assessed using the PAL task. Performance will be compared between the prucalopride and placebo groups.",[58,62,65,69,72,76],{"measure":59,"description":60,"timeFrame":61},"State Subjective Cognition Scale (SSCS)","Subjective cognitive functioning will be assessed using the State Subjective Cognition Scale (SSCS). Responses will be compared between the prucalopride and placebo groups.","Baseline and daily during the 14-day intervention.",{"measure":63,"description":64,"timeFrame":61},"Positive and Negative Affect Schedule (PANAS)","Positive and negative affect will be assessed using the PANAS. Scores will be compared between the prucalopride and placebo groups.",{"measure":66,"description":67,"timeFrame":68},"Patient Health Questionnaire-9 (PHQ-9)","Depressive symptoms will be assessed using the PHQ-9. Scores will be compared between the prucalopride and placebo groups.","Baseline, Day 7 and Day 14 of the intervention",{"measure":70,"description":71,"timeFrame":68},"Perceived Deficits Questionnaire (PDQ)","Subjective cognitive difficulties will be assessed using the PDQ. Scores will be compared between the prucalopride and placebo groups.",{"measure":73,"description":74,"timeFrame":75},"Generalized Anxiety Disorder-7 (GAD-7)","Anxiety symptoms will be assessed using the GAD-7. Scores will be compared between the prucalopride and placebo groups.","Baseline, Day 7 and Day 14 of the intervention.",{"measure":77,"description":78,"timeFrame":75},"Temporal Experience of Pleasure Scale (TEPS)","Anticipatory and consummatory pleasure will be assessed using the TEPS. Scores will be compared between the prucalopride and placebo groups.",{"allocation":80,"interventionModel":81,"interventionModelDescription":82,"primaryPurpose":83,"observationalModel":84,"timePerspective":84,"maskingInfo":85},"RANDOMIZED","PARALLEL","Participants randomised to a active medication group (n=30) or placebo group (n=30)","BASIC_SCIENCE",null,{"masking":86,"maskingDescription":84,"whoMasked":87},"TRIPLE",[88,89,90],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Cognitive symptoms are common in depression and can persist even when other symptoms of depression have improved. These difficulties can include impairments in memory, attention and executive function, and there remains a need for treatments that specifically target cognitive dysfunction associated with depression.\n\nEvidence from preclinical and human experimental studies suggests that activation of the serotonin 4 receptor (5-HT4R) may represent a potential therapeutic approach for targeting cognitive symptoms in depression. The 5-HT4R is expressed in brain regions involved in learning and memory, and experimental studies have investigated whether selective activation of this receptor can influence cognitive processes relevant to depression.\n\nPrucalopride is a selective 5-HT4R agonist. In previous human experimental studies, we have found evidence that prucalopride can influence cognitive processes, including learning and memory, in healthy volunteers and people who have recovered from depression. The present study extends this work by investigating the cognitive effects of prucalopride in people who are currently experiencing low mood.\n\nThe study will use an experimental medicine approach to examine the effects of 5-HT4R activation on cognitive processes relevant to depression. In addition, the study will investigate the effect of prucalopride on sleep architecture. Sleep will be assessed in the home environment using wearable chest patches capable of sleep staging.\n\nThe study will provide proof-of-concept evidence regarding the effects of 5-HT4R activation on cognition and sleep in people experiencing low mood. These data will inform the design and feasibility of a future randomised controlled trial evaluating prucalopride in people with depression and cognitive impairment.",[93,99],{"label":94,"type":95,"description":96,"interventionNames":97},"Prucalopride","EXPERIMENTAL","Participants will receive daily oral prucalopride for 14 days.",[98],"Drug: Prucalopride",{"label":100,"type":101,"description":102,"interventionNames":103},"Placebo","PLACEBO_COMPARATOR","Participants will receive daily oral placebo for 14 days.",[104],"Drug: Placebo Comparator",[106,110],{"type":107,"name":94,"description":108,"armGroupLabels":109,"otherNames":84},"DRUG","Prucalopride will be administered orally once daily for 14 days. Participants will receive 1 mg once daily on Days 1-2 and 2 mg once daily on Days 3-14.",[94],{"type":107,"name":111,"description":112,"armGroupLabels":113,"otherNames":84},"Placebo Comparator","A matching placebo (lactose) will be administered orally once daily for 14 days. Participants will take one placebo capsule on Days 1-2 and two placebo capsules on Days 3-14, matching the dosing schedule of the prucalopride intervention.",[100],[115],{"name":116,"affiliation":117,"role":118},"Susannah E Murphy, DPhil","Department of Psychiatry, University of Oxford","PRINCIPAL_INVESTIGATOR",[120,125],{"name":121,"role":122,"phone":123,"phoneExt":84,"email":124},"Susannah Murphy, PhD","CONTACT","+441865618313","susannah.murphy@psych.ox.ac.uk",{"name":126,"role":122,"phone":127,"phoneExt":84,"email":128},"Finley T Watton, MBiomedSci Neurosciences","+447593941882","finley.watton@psych.ox.ac.uk",[130],{"facility":131,"status":84,"city":132,"state":133,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":142,"contacts":143},"Warneford Hospital","Oxford","Oxfordshire","OX3 7JX","United Kingdom","UK",{"type":138,"coordinates":139},"Point",[140,141],-1.25596,51.75222,{"lat":141,"lon":140},[144,145],{"name":121,"role":122,"phone":123,"phoneExt":84,"email":124},{"name":116,"role":118,"phone":84,"phoneExt":84,"email":84},{"type":147,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR","100658276","promote-effects-of-5-ht4-agonism-on-cognition-and-sleep-in-peopl-with-low-mood-100658276",false,"NCT07848477","PROMOTE: Effects of 5-HT4 Agonism on Cognition and Sleep in Peopl With Low Mood","Investigating the Effect of 5-HT4 Receptor Agonism on Cognition and Sleep in People With Low Mood","PROMOTE","Inclusion Criteria:\n\n* Aged between 18-65\n* Male or female\n* Participant is willing and able to give informed consent for participation in the research\n* Body mass index in the range of 18-35 inclusive\n* Current PHQ-9 score in the range of 9-15\n\nExclusion Criteria:\n\n* Any current or previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD or PTSD.\n* A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia\n* Body Mass Index outside the range of 18 to 35 inclusive\n* Any significant current medical condition likely to interfere with conduct of the study or analysis of data\n* Current use of psychoactive and \u002F or medically significant medication as judged by a study medic, whether prescribed or bought over the counter (the contraceptive pill, the Depo-Provera injection or the progesterone implant will not result in exclusion)\n* Ongoing psychopharmacological treatment for depression, including hypnotics (psychotherapy will be allowed as long as not newly-started in the last 6 weeks)\n* High consumption of illicit substances to an extent that would make complying with study protocol challenging (including alcohol, caffeine, nicotine)\n* Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study\n* Currently pregnant, trying to get pregnant, or breast feeding\n* Current, or a significant history of, gastro-intestinal disorder or irritable bowel syndrome\n* Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose\n* Participation in a study that involves the use of a medication or novel vaccine within the last three months\n* Participation in a study using the same tasks in the last year\n* Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging, including yellow\u002Fblue colourblindness\n* A head injury causing concussion or loss of consciousness within the last six months\n* Moderate to high risk of suicide or self-harm\n* Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Chief Investigator.\n\nAdditional Exclusion Criteria for Participants in the Sleep Study Cohort:\n\n* Unable to undergo cardiac monitoring\n* Unable to wear the sleep patch device for full monitoring period\n* Implanted neurostimulator or pacemaker","ALL","18 Years","65 Years",{"count":160,"type":161},60,"ESTIMATED","INTERVENTIONAL",[164],"NA","Serotonin is a chemical in the brain that plays an important role in mood, sleep, and other functions. It works by attaching to different types of serotonin receptors on brain cells. These receptors act like \"locks\", with serotonin acting like a \"key\". Different types of serotonin receptors have different effects in the brain.\n\nPrucalopride is a licensed medication used to treat constipation. It acts on a particular serotonin receptor, called the serotonin 4 receptor. Researchers are interested in this receptor because understanding how it works in the brain may help us learn more about depression and could contribute to the development of new treatments in the future.\n\nThe purpose of this study is to investigate the effects of prucalopride in people experiencing low mood. We will compare prucalopride with a placebo (a treatment with no active medication) to find out whether activating the serotonin 4 receptor affects sleep and aspects of thinking, including memory, attention and decision making.",[167,168],"Low Mood","Depression - Major Depressive Disorder",[167,170,171,172,173,174,175],"Cognition","Sleep","Depression","prucalopride","5-HT4 receptor","cognitive function","NOT_YET_RECRUITING","2026-10-01",{"date":179,"type":180},"2026-10-06","ACTUAL",{"date":182,"type":161},"2026-10",{"date":184,"type":161},"2028-07",{"name":5,"class":6},1]